Cystic Fibrosis Clinical Trial
Official title:
The Role of IL-17 Neutrophils in CF Lung Inflammation
The purpose of this study is to determine whether IL-17 polymorphonuclear leukocytes (PMNs) are central to the disease pathology in CF. This will be determined by demonstrating that IL-17 PMNs are present in the CF airway, correlate with lung function measures, and decrease in patients being treated with IV antibiotics for a pulmonary exacerbation.
This study consists of two parts which will be conducted in parallel. In the first part of
the study, 14 subjects will be recruited for the Clinically Stable Cohort. Subjects will be
asked to provide 1 gm of expectorated sputum and 40-ml of blood. A cell count and
differential will be performed on the sputum followed by analysis for IL-17 PMNs by
fluorescence-activated cell sorter (FACS). IL-17 PMNs also will be isolated by running the
remainder of the cell pellet through a column of magnetic beads designed for this purpose.
These neutrophils will be lysed and intracellular cytokines determined. Sputum supernatants
will be stored frozen until analyzed for the presence of IL-1β, IL-6, IL-8, IL-17A, TGF-β,
TNF-α, and neutrophil elastase. Clinical data will be captured from the subject's clinical
outpatient visit including lung function measures and clinical culture results. IL-17 PMNs
will be correlated with lung function measures and inflammatory mediators at baseline.
In the second part of this study, 10 subjects will be recruited for the Exacerbation Cohort.
Subjects will provide at least 1 gram of expectorated sputum and 40-ml of blood within 72
hours of hospital admission. Sputum and blood will be processed and analyzed as described
above. Sputum and blood also will be obtained at the end of treatment (within 72 hours of
completion of IV antibiotics) when the subject is at his or her baseline as determined by the
managing physician. Clinical data will be captured from the subject's hospitalization records
including lung function measures and clinical culture results.
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